The authors suggested that the higher proportion of patients in the fluorouracil group who were willing to undergo a second round of therapy suggests they may have experienced less discomfort and inconvenience with the therapy to begin with, compared with those treated with the other regimens.
Full adherence to treatment was more common in the ingenol mebutate (98.7% of patients) and MAL-PDT (96.8%) groups, compared with the fluorouracil (88.7%) and imiquimod (88.2%) groups. However, patients in the fluorouracil group reported greater levels of patient satisfaction and improvements in health-related quality of life than did patients in the other treatment arms of the study.
No serious adverse events were reported with any of the treatments, and no patients stopped treatment because of adverse events. However, reports of moderate or severe crusts were highest among patients treated with imiquimod, and moderate to severe vesicles or bullae were highest among those treated with ingenol mebutate. Severe pain and severe burning sensation were significantly more common among those treated with MAL-PDT.
While the study had some limitations, the results “could affect treatment choices in both dermatology and primary care,” the authors wrote, pointing out how common AKs are in practice, accounting for 5 million dermatology visits in the United States every year. When considering treatment costs, “fluorouracil is also the most attractive option,” they added. “It is expected that a substantial cost reduction could be achieved with more uniformity in care and the choice for effective therapy.”
The study was supported by the Netherlands Organization for Health Research and Development. Five of the 11 authors declared conference costs, advisory board fees, or trial supplies from private industry, including from manufacturers of some of the products in the study. The remaining authors had no disclosures.
SOURCE: Jansen M et al. N Engl J Med. 2019;380:935-46.